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A Study of a Sleep Supplement to Improve Sleep in Women Going Through Menopause

NCT07375095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-01-29

No results posted yet for this study

Summary

This study evaluated whether a daily dietary sleep supplement could improve sleep in women aged 40 to 65 who experience moderate sleep disturbances during menopause. Participants were randomly assigned to take either the supplement or a placebo for about three weeks. All study visits were conducted virtually. Sleep was assessed through daily diaries and weekly questionnaires measuring sleep quality, nighttime awakenings, daytime alertness, and mood. The study's goal was to compare changes between the supplement and placebo groups and to assess safety and tolerability during the study period.

Conditions

  • Sleep Disturbance

Interventions

DIETARY_SUPPLEMENT

Sleep Supplement

A daily dietary sleep supplement taken once per day for 21 days.

DRUG

Placebo

A placebo matched in appearance and dosing schedule to the sleep supplement, taken once per day for 21 days.

Sponsors & Collaborators

  • Bonafide Health

    lead INDUSTRY

Principal Investigators

  • Trisha VanDusseldorp, PhD · Bonafide Health, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2024-04-07
Completion
2024-04-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07375095 on ClinicalTrials.gov